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Low-dose Hydrocortisone in Acutely Burned Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149123
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 12, 2015
Sponsor:
Information provided by:
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date February 12, 2015
Study Start Date  ICMJE April 2005
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
Number of patients who do not receive any more catecholamine 4 days after the beginning of the shock
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00149123 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
  • Duration of catecholamine administration
  • Doses of administered catecholamine
  • Adrenal insufficiency incidence
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-dose Hydrocortisone in Acutely Burned Patients
Official Title  ICMJE Low-dose Hydrocortisone in the Treatment of the Shock of Burned Patients
Brief Summary Major burns trigger the release of circulating mediators, as cytokines and endotoxin that induces a systemic inflammatory response syndrome. The cardiovascular effects are similar to those seen in septic shock. After the initial hypovolemic phase, patients with extensive burns often present a shock with increased cardiac output and reduced systemic vascular resistances. As described in septic shock, we test the hypothesis that low-dose hydrocortisone could decrease the duration of the shock period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Burns
Intervention  ICMJE Drug: hydrocortisone 200 mg/day
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 6, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • males and females,
  • between 18 and 75 year old
  • who present a burned surface more than 30% of the body surface
  • who need catecholamine infusion
  • between J0 and J3 after the injury.

Exclusion Criteria:

  • pregnancy,
  • trauma,
  • sepsis,
  • cardiac insufficiency,
  • AIDS,
  • etomidate administration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00149123
Other Study ID Numbers  ICMJE 2004.354
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sylvie TISSOT, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP